Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.

Condition(s) targeted: Critical Ill Patients in SICU

Intervention: Omegaven 10% (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Hong-Shiee Lai, Professor, Principal Investigator, Affiliation: National Taiwan University Hospital, Taipei, Taiwan

Overall contact:
Hong-Shiee Lai, MD, PhD, Phone: 886-2-23123456, Ext: 5112, Email: hslai@ha.mc.ntu.edu.tw

1. A prospective, controlled, randomized, study evaluating the clinical efficacy, including nutritional status, immune function and safety of Omegaven (ω-3 fish oil) supplemented parenteral nutrition in subjects of SICU.

2. Study patients are the critical ill patients in SICU of NTUH and the enrolled patients will be 30 subjects ,including 15 in each treatment group.

3. During parenteral nutrition, fat emulsions will be given separately from amino acid and glucose solutions. Infusion pump must be used. The recommended infusion duration of the daily lipid emulsion is 16 hours (0. 0625 g fat/kg B. W./hour) from 8: 00 am to 12: 00 pm.

4. During the study the assessments of safety and efficacy are to be performed according to case report form. The assessment for safety variables including blood pressure、heat rate 、body temperature、liver function、renal function、coagulation、WBC、lipid profile etc. In addition，the assessments for efficacy variables including lymphocytes、cytokines(IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40 ligand、G-CSF、FN-γ、TGF-β1、TNF-α etc)、incidence of infections、 length of ICU and hospital stay、mortality etc.

Official title: A Prospective, Controlled, Randomized, Study Evaluating the Clinical Efficacy, Including Nutritional Status, Immune Function and Safety of Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Lymphocytes:T4,T8,B,T,NK

Cytokine secretion:IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40 ligand、G-CSF、FN-γ、TGF-β1、TNF-α.

Clinical outcome:incidence of infections,length of ICU and hospital stay,ventilation,mortality

Secondary outcome:

Liver function(AST,ALT,bilirubin,ALP,rGT,albumin)

renal function(BUN,creatinine)

AC blood sugar

coagulation(INR,aPTT)

sodium

potassium

chloride

calcium

magnesium

phosphate

total white blood cell counts

platelets

haemoglobin

haematoc

Detailed description: 1. A prospective, controlled, randomized, study evaluating the clinical efficacy, including nutritional status, immune function and safety of Omegaven (ω-3 fish oil) supplemented parenteral nutrition in subjects of SICU.

2. Study patients are the critical ill patients in SICU of NTUH and the enrolled patients will be 30 subjects ,including 15 in each treatment group.

3. During parenteral nutrition, fat emulsions will be given separately from amino acid and glucose solutions. Infusion pump must be used. The recommended infusion duration of the daily lipid emulsion is 16 hours (0. 0625 g fat/kg B. W./hour) from 8: 00 am to 12: 00 pm.

4. During the study the assessments of safety and efficacy are to be performed according to case report form. The assessment for safety variables including blood pressure、heat rate 、body temperature、liver function、renal function、coagulation、WBC、lipid profile etc. In addition，the assessments for efficacy variables including lymphocytes、cytokines(IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40 ligand、G-CSF、FN-γ、TGF-β1、TNF-α etc)、incidence of infections、 length of ICU and hospital stay、mortality etc.

Minimum age: 15 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female patients between 15 and 75 years of age

- Expected ICU stay and TPN support requirement > 7 days

- Hemodynamically stable

- Serum bilirubin < 2. 5 mg/dl

- Serum creatinine < 1. 4 mg/dl

- INR (international Normalized ratio of PT) < 1. 4

- Written informed consent from the subject

Exclusion Criteria:

- Pregnant or lactating women. (Pre-menopause women, capable of bearing children will

undergo pregnancy test)

- General contraindications of infusion therapy; acute pulmonary oedema,hyperhydration

and decompensated cardiac insufficiency

- Known hypersensitivity to egg- or soy protein or any of the ingredients

- Severe blood coagulation disorders

- Shock necessitating acute resuscitation at the discretion of the investigator

- Diabetes mellitus with known ketoacidosis within 7 days of onset of study treatment

- APACHE II score > 25

- Renal insufficiency defined as serum creatinine value of >1. 4 mg/dl

- Subjects with severe liver dysfunction which contraindicates the use of parenteral

nutrition at the discretion of the investigator

- Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia

(at the time of inclusion, a blood sample (fasting) for serum triglyceride assessment has to be taken. The sample has to be analysed before start of trial treatment. In case of fasting serum triglyceride value of >4 mmol/l (>354 mg/dl) the subject must be withdrawn.

- Unconscious or uncooperative patients

- Participation in a clinical study with an investigational drug or an investigational

medical device within one month prior to start of study

Hong-Shiee Lai, MD, PhD, Phone: 886-2-23123456, Ext: 5112, Email: hslai@ha.mc.ntu.edu.tw

National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting
Hong-Shiee Lai, M.D., Ph.D., Phone: 886-2-23123456, Ext: 5112, Email: hslai@ha.mc.ntu.edu.tw

Related publications:

Roulet M, Frascarolo P, Pilet M, Chapuis G. Effects of intravenously infused fish oil on platelet fatty acid phospholipid composition and on platelet function in postoperative trauma. JPEN J Parenter Enteral Nutr. 1997 Sep-Oct;21(5):296-301.

Starting date: March 2005
Ending date: March 2007
Last updated: September 12, 2005